Recombinant protein manufacturing for therapeutic proteins of clinical value has been a huge technical and commercial success of the biotechnology industry. Monoclonal antibodies (MAbs) had global sales in 2006 of $20.6 billion and are the fastest growing pharmaceutical segment. Six of the top selling US MAbs have sales over $1 billion annually with Rituxan® alone topping $4.7 billion in sales.
The utilization of MAbs for national defense is of keen interest to agencies mandated with the treatment of bioweapons casualties (and large scale epidemics of infectious diseases, e.g., SARS). Military and civilian research programs have identified several therapeutic MAbs and in some cases have begun the process of developing them as medical countermeasures for biological weapons.
Two issues must be addressed if MAbs are to be deployed as first line countermeasures: high drug cost and cumbersome delivery systems. The cost of manufacturing “biologics” is high. Recombinant proteins, like MAbs, are produced by a costly process involving large scale cGMP manufacturing and eukaryotic/prokaryotic fermentation systems, followed by downstream purification and polishing of the finished bulk pharmaceutical active. Secondly, the delivery of MAbs and other protein-based drugs via injection has been a therapeutic barrier. The large scale use of MAbs via conventional injection or infusion is impractical within the time and human resources constraints of a bioweapons attack on the battlefield or in a terrorist scenario.